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NCT01921400 · ClinicalTrials.gov registry record
The Pathogenesis of Hepatitis C Virus Vertical Transmission
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 38
- Enrollment target
NCT01921400: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01921400 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921400 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study Summary
To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples. Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed. Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.
Primary Outcome
We will begin by examining paraffin-embedded sections from HCV-infected mothers who had the placentas sent to pathology for analysis.We will perform a combination of immunohistochemistry (IHC) and immunofluorescence (IF) to analyze the level of SPP expression in the trophoblast cell layer, as well as if HCV Core protein expression was detectable in this layer or in any cell type within the placental section. We would also plan to identify other patient-derived tissues that were not paraffin emb
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-12 |
What the finished NCT01921400 record still lists
NCT01921400 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01921400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01921400 about?
NCT01921400 is a clinical study titled "The Pathogenesis of Hepatitis C Virus Vertical Transmission". To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique an...
What is the current status of trial NCT01921400?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2013-01. Estimated completion is 2017-12.
Who is sponsoring clinical trial NCT01921400?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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